Enable validated systems to achieve quality, safety and patient satisfaction goals by synchronizing our mature process with healthcare and technology expertise.

Navitas Healthcare Practice:

Pharmaceutical, Clinical, Healthcare Technology and Medical Device systems companies are facing some big challenges—and big opportunities. But price pressures, growing competition and a number of other significant issues mean that success isn’t automatic, even in a rapidly growing field. There are five business imperatives that every healthcare technology and medical device systems companies needs to address:

  • Time to Market
  • Develop Alliances
  • Integration and Interoperability
  • Continuous Product Enhancement
  • Compliance and Certification

Navitas offers outsourcing services to Healthcare Technology and Medical Device Systems companies in areas such as: software design, development, verification & validation, integration, quality assurance, testing, and enterprise IT functions. Our device to application integration CoE and a strong regulatory practice provides regulatory support at every stage of the lifecycle.

Why Navitas:

Business Relationships - NAVITAS works with globally renown Healthcare Technology and Medical Device Companies

Experience and Quality System - NAVITAS is ISO 9001:2000, and has experience in 21 CFR Part 830, 820 (QSR) standards for UDI.

Compliance - 21CFR Part 11 compliance expertise strengthened by Regulatory Affairs Consultants

Our technology services spectrum includes:

  • Product Development
  • Verification and Validation
  • Quality Assurance
  • Compliance
  • Integration

Product Development - Navitas ’s seasoned team has the depth and breadth of experience to quickly understand your culture, your technology, and your objectives. That means we can get your project off to a fast, flawless start. We have assisted our clients launch everything from sophisticated Medical management systems to state-of-the-art diagnostic imaging technologies. Our mature product development methodology and global delivery model have enabled out client to achieve quicker time to market at most optimal costs.

Verification and Validation – Navitas ’s skilled and highly qualified V&V practice offers solution for your product testing need. Our software validation services are highly process driven throughout the product development lifecycle. Our validation engineers work with the client’s processes, or can supplement client processes with Navitas ’s processes. Our validation team works with clients in a hands-on, consultative, or training role on areas of expertise including: Verification and Validation SOP Development, V&V Planning, Requirements Management and Traceability, Test Design, Test Case, Test Procedure Development, System, Integration, and Unit Level Testing, Regression Test Planning, Defect/Issue Tracking and Management, User Testing.

Compliance - Navitas has assisted several large health IT companies and their products comply with various industry standards. Some of recent engagements include gap analysis and verification of a GXP and sox application with respect to Pharma, medical device compliance for a per-operating system, Ensuring DICOM compliance for a hospital information system, product enhancement to meet FDA and USDA compliance. Navitas also provided strategic consulting services for federal agencies and healthcare entities to migrate systems and processes from ICD-9 to ICD-10. NAVITAS is experience in 21 CFR Part 11, 820, 830 and other (QSR) standards.

Quality Assurance - A key trend among health IT companies is the deployment of external independent quality assurance to increase the quality, reduce defects and maintain the integrity of product releases. Health IT companies have leveraged Navitas’s global quality assurance team to perform stringent product testing and quality assurance. Besides functional testing using automated test platforms, Navitas assists its clients in performing scalability testing, interoperability testing and usability testing. Clients engage Navitas is multiple ways such as turn-key testing, dedicated global QA team, and on-demand onsite testing resources.